Study of CM310 in Healthy Subjects

Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06161090

Enrollment

Registered

2023-12-07

Start date

2019-09-03

Completion date

2020-01-13

Last updated

2023-12-07

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, double-blind, placebo-controlled, dose escalation study.

Interventions

BIOLOGICALCM310

CM310 injection

DRUGPlacebo

subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers. * aged ≥ 18 and ≤ 65 years old. * With all clinical laboratory examination normal. * Voluntary signing of the informed consent form.

Exclusion criteria

* With a history of asthma and allergic reactions. * With a history of conjunctivitis and keratitis, as well as previous medical conditions. * With positive results from alcohol breath or urine drug abuse testing.

Design outcomes

Primary

Measure	Time frame	Description
Adverse event	up to Week 9	Incidence of adverse events.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026