A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05638282

Enrollment

Registered

2022-12-06

Start date

2023-02-15

Completion date

2023-06-27

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Healthy, Chinese, Cendakimab

Brief summary

The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.

Interventions

DRUGCendakimab

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants must be Chinese (both biological parents are ethnically Chinese). * Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m\^2), inclusive. BMI = weight (kg)/\[height (m)\]\^2. * Body weight ≥ 50.0 kg.

Exclusion criteria

* History of clinically significant infection within 4 weeks of dosing on Day 1. * Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. * Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Maximum Observed Serum Concentration (Cmax)	Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))	Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))	Predose and at multiple timepoints (up to 105 days) after dosing

Secondary

Measure	Time frame
Number of Participants with Clinically Significant Changes in Physical Examinations	Screening (Days -28 to -1) through Day 105
Number of Participants with Treatment-emergent Adverse Events	Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Electrocardiograms	Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests	Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs	Screening (Days -28 to -1) through Day 105

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026