Nonclinical precedent Request an invite
Atlas/Monoclonal antibodies/Cinqair/First dose

Cinqair: how was the first human dose set?

reslizumab · IL-5
Check my plan vs. these
First-in-human starting dose
Phase 1 single-dose escalation in severe asthma at 0.03 to 1.0 mg/kg; derivation of starting dose not described
“This product has been used in Europe in an initial phase 1 single dose, dose escalation trial for treatment of 32 subjects with severe asthma (I96-350). Doses ranged from 0.03 mg/kg to 1.0 mg/kg.”
✓ VerifiedFDA pharmacology/toxicology review, p. 125Source ↗
NOAEL / key findings
NOAEL 25 mg/kg (highest dose) in mice and monkeys; no target organs; about 3-fold exposure margin
“The NOAELs of 25 mg/kg provided a safety margin of approximately 3-fold compared to the recommended clinical dose based on systemic exposure comparisons.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗

Same question, other monoclonal antibodies

Anthim

obiltoxaximab · B. anthracis PA
Single-dose clinical escalation supported by monkey AUC margin: 10 mg/kg AUC ~50,000 µg·hr/mL vs human AUC 10,000 at 114 mg

Danyelza

naxitamab · GD2
Initial trials based on prior clinical data with the murine parent antibody, not on toxicology data with naxitamab

Imaavy

nipocalimab · FcRn
First-in-human SAD in healthy volunteers started at 0.3 mg/kg IV, escalating to 60 mg/kg; derivation not stated

Rituxan

rituximab · CD20
Based on monkey pilot study relating multiple-dose rituximab exposure to B-cell depletion

Sarclisa

isatuximab · CD38
MABEL and in vitro receptor occupancy: 0.0001 mg/kg, about 10% predicted CD38 occupancy in B and T cells

Actemra

tocilizumab · IL-6R
Not stated in public reviews

Adakveo

crizanlizumab · P-selectin
Not stated in public reviews

Adbry

tralokinumab · IL-13
Not stated in public reviews

Aduhelm

aducanumab · Aggregated amyloid-β
Not stated in public reviews

Aimovig

erenumab · CGRP receptor
Not stated in public reviews

Ajovy

fremanezumab · CGRP
Not stated in public reviews

Alhemo

concizumab · TFPI
Not stated in public reviews

Andembry

garadacimab · Factor XIIa
Not stated in public reviews

Arzerra

ofatumumab · CD20
Not stated in public reviews

Avastin

bevacizumab · VEGF-A
Not stated in public reviews

Bavencio

avelumab · PD-L1
Not stated in public reviews

Benlysta

belimumab · BLyS (BAFF)
Not stated in public reviews

Beovu

brolucizumab · VEGF-A
Not stated in public reviews

Beyfortus

nirsevimab · RSV F protein
Not stated in public reviews

Bimzelx

bimekizumab · IL-17A/IL-17F
Not stated in public reviews

Briumvi

ublituximab · CD20
Not stated in public reviews

Cablivi

caplacizumab · von Willebrand factor (A1 domain)
Not stated in public reviews

Campath

alemtuzumab · CD52
Not stated in public reviews

Cimzia

certolizumab pegol · TNF-α
Not stated in public reviews

Cosentyx

secukinumab · IL-17A
Not stated in public reviews

Crysvita

burosumab · FGF23
Not stated in public reviews

Cyramza

ramucirumab · VEGFR2
Not stated in public reviews

Darzalex

daratumumab · CD38
Not stated in public reviews

Dupixent

dupilumab · IL-4Ra
Not stated in public reviews

Ebanga

ansuvimab · Zaire ebolavirus glycoprotein
Not stated in public reviews

Ebglyss

lebrikizumab · IL-13
Not stated in public reviews

Emgality

galcanezumab · CGRP
Not stated in public reviews

Empliciti

elotuzumab · SLAMF7
Not stated in public reviews

Enflonsia

clesrovimab · RSV F protein (site IV)
Not stated in public reviews

Enjaymo

sutimlimab · Complement C1s
Not stated in public reviews

Enspryng

satralizumab · IL-6R
Not stated in public reviews

Entyvio

vedolizumab · α4β7-integrin
Not stated in public reviews

Erbitux

cetuximab · EGFR
Not stated in public reviews

Evenity

romosozumab · Sclerostin
Not stated in public reviews

Evkeeza

evinacumab · ANGPTL3
Not stated in public reviews

Exdensur

depemokimab · IL-5
Not stated in public reviews

Fasenra

benralizumab · IL-5Rα
Not stated in public reviews

Gamifant

emapalumab · IFN-γ
Not stated in public reviews

Gazyva

obinutuzumab · CD20
Not stated in public reviews

Herceptin

trastuzumab · HER2
Not stated in public reviews

Humira

adalimumab · TNF-α
Not stated in public reviews

Hympavzi

marstacimab · TFPI
Not stated in public reviews

Ilaris

canakinumab · IL-1β
Not stated in public reviews

Ilumya

tildrakizumab · IL-23 p19
Not stated in public reviews

Imfinzi

durvalumab · PD-L1
Not stated in public reviews

Imjudo

tremelimumab · CTLA-4
Not stated in public reviews

Jemperli

dostarlimab · PD-1
Not stated in public reviews

Kevzara

sarilumab · IL-6R
Not stated in public reviews

Keytruda

pembrolizumab · PD-1
Not stated in public reviews

Kisunla

donanemab · Amyloid-β (N3pG)
Not stated in public reviews

Lartruvo

olaratumab · PDGFRα
Not stated in public reviews

Leqembi

lecanemab · Amyloid-β protofibrils
Not stated in public reviews

Libtayo

cemiplimab · PD-1
Not stated in public reviews

Loqtorzi

toripalimab · PD-1
Not stated in public reviews

Lucentis

ranibizumab · VEGF-A
Not stated in public reviews

Margenza

margetuximab · HER2
Not stated in public reviews

Monjuvi

tafasitamab · CD19
Not stated in public reviews

Nemluvio

nemolizumab · IL-31RA
Not stated in public reviews

Niktimvo

axatilimab · CSF-1R
Not stated in public reviews

Nucala

mepolizumab · IL-5
Not stated in public reviews

Ocrevus

ocrelizumab · CD20
Not stated in public reviews

Omvoh

mirikizumab · IL-23 p19
Not stated in public reviews

Opdivo

nivolumab · PD-1
Not stated in public reviews

Pasatru

garetosmab · Activin A
Not stated in public reviews

Penpulimab

penpulimab · PD-1
Not stated in public reviews

Perjeta

pertuzumab · HER2
Not stated in public reviews

Piasky

crovalimab · Complement C5
Not stated in public reviews

Portrazza

necitumumab · EGFR
Not stated in public reviews

Poteligeo

mogamulizumab · CCR4
Not stated in public reviews

Praluent

alirocumab · PCSK9
Not stated in public reviews

Praxbind

idarucizumab · Dabigatran
Not stated in public reviews

Prolia

denosumab · RANKL
Not stated in public reviews

Raxibacumab

raxibacumab · B. anthracis protective antigen
Not stated in public reviews

Remicade

infliximab · TNF-α
Not stated in public reviews

Repatha

evolocumab · PCSK9
Not stated in public reviews

Rystiggo

rozanolixizumab · FcRn
Not stated in public reviews

Saphnelo

anifrolumab · IFNAR1
Not stated in public reviews

Siliq

brodalumab · IL-17RA
Not stated in public reviews

Simponi

golimumab · TNF-α
Not stated in public reviews

Simulect

basiliximab · IL-2Rα (CD25)
Not stated in public reviews

Skyrizi

risankizumab · IL-23 p19
Not stated in public reviews

Soliris

eculizumab · Complement C5
Not stated in public reviews

Spevigo

spesolimab · IL-36R
Not stated in public reviews

Stelara

ustekinumab · IL-12/23 p40
Not stated in public reviews

Sylvant

siltuximab · IL-6
Not stated in public reviews

Synagis

palivizumab · RSV F protein
Not stated in public reviews

Takhzyro

lanadelumab · Plasma kallikrein
Not stated in public reviews

Taltz

ixekizumab · IL-17A
Not stated in public reviews

Tecentriq

atezolizumab · PD-L1
Not stated in public reviews

Tepezza

teprotumumab · IGF-1R
Not stated in public reviews

Tevimbra

tislelizumab · PD-1
Not stated in public reviews

Tezspire

tezepelumab · TSLP
Not stated in public reviews

Tremfya

guselkumab · IL-23 p19
Not stated in public reviews

Trogarzo

ibalizumab · CD4
Not stated in public reviews

Tysabri

natalizumab · α4-integrin
Not stated in public reviews

Tzield

teplizumab · CD3
Not stated in public reviews

Ultomiris

ravulizumab · Complement C5
Not stated in public reviews

Unituxin

dinutuximab · GD2
Not stated in public reviews

Unloxcyt

cosibelimab · PD-L1
Not stated in public reviews

Uplizna

inebilizumab · CD19
Not stated in public reviews

Vectibix

panitumumab · EGFR
Not stated in public reviews

Veopoz

pozelimab · Complement C5
Not stated in public reviews

Voyxact

sibeprenlimab · APRIL
Not stated in public reviews

Vyepti

eptinezumab · CGRP
Not stated in public reviews

Vyloy

zolbetuximab · Claudin 18.2
Not stated in public reviews

Xolair

omalizumab · IgE
Not stated in public reviews

Yartemlea

narsoplimab · MASP-2
Not stated in public reviews

Yervoy

ipilimumab · CTLA-4
Not stated in public reviews

Zinbryta

daclizumab · IL-2Rα (CD25)
Not stated in public reviews

Zinplava

bezlotoxumab · C. difficile toxin B
Not stated in public reviews

Zynyz

retifanlimab · PD-1
Not stated in public reviews

Summary across all 117 monoclonal antibodies →