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RECRUITING
NCT07182656
PHASE1

Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants

Sponsor: Yi Fang

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.

Official title: A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Doses of CIGB-814 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-08-18

Completion Date

2026-04-30

Last Updated

2025-09-19

Healthy Volunteers

Yes

Interventions

DRUG

CIGB-814 (single-dose group)

CIGB-814, single ascending dose, SC injection

DRUG

CIGB-814 placebo (single-dose group)

CIGB-814 placebo, single ascending dose, SC injection

DRUG

CIGB-814 (multiple-dose group)

CIGB-814, multiple ascending dose, SC injection

DRUG

CIGB-814 placebo (multiple-dose group)

CIGB-814 placebo, multiple ascending dose, SC injection

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China