RecruitingPhase 1NCT07182656

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

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


Sponsor

Yi Fang

Enrollment

70 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This is an early-stage safety study of a new drug called CIGB-814 in healthy adult volunteers in China. The study is evaluating how safe the drug is and how the body processes it before it is tested in patients with disease. **You may be eligible if...** - You are a healthy adult between 18 and 45 years old - You weigh at least 50 kg (if male) or 45 kg (if female), with a BMI between 19 and 26 - You have no plans for pregnancy during the study and for 6 months after - You are willing and able to follow all study procedures and attend all required visits **You may NOT be eligible if...** - You have any significant health conditions, allergies, or chronic diseases - You are pregnant, breastfeeding, or planning a pregnancy during the study period - You have participated in another clinical trial recently - You smoke, drink heavily, or use recreational drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCIGB-814 (single-dose group)

CIGB-814, single ascending dose, SC injection

DRUGCIGB-814 placebo (single-dose group)

CIGB-814 placebo, single ascending dose, SC injection

DRUGCIGB-814 (multiple-dose group)

CIGB-814, multiple ascending dose, SC injection

DRUGCIGB-814 placebo (multiple-dose group)

CIGB-814 placebo, multiple ascending dose, SC injection


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07182656


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