Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06171048

Enrollment

236

Registered

2023-12-14

Start date

2024-04-30

Completion date

2025-04-30

Last updated

2023-12-14

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

Conditions

Healthy

Brief summary

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Detailed description

This study includes screening and treatment and follow-up periods.

Interventions

BIOLOGICALCM310

CM310 injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 20 years ≤ age ≤ 45 years. * Voluntarily participate in the study and sign the ICF. * Have the ability to understand the study.

Exclusion criteria

* With history of chronic or serious illness. * With any medication within 28 days prior to administration; * Plan to undergo surgery during the research period; * With any situations unsuitable to participate in this study.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic: the maximum concentration (Cmax)	up to week 6	Concentration and exposure

Countries

China

Contacts

Primary ContactQian Jia

qianjia@keymedbio.com028-88610620

Outcome results

None listed

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