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

NCT07182656 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

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

Sponsors & Collaborators

  • Yi Fang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07182656 on ClinicalTrials.gov