---
title: Study of CM310 in Healthy Subjects
nct_id: NCT06161090
overall_status: COMPLETED
phase: PHASE1
sponsor: Keymed Biosciences Co.Ltd
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06161090.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06161090"
ct_last_update_post_date: 2023-12-07
last_seen_at: "2026-05-12T06:06:35.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of CM310 in Healthy Subjects

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

**NCT ID:** [NCT06161090](https://clinicaltrials.gov/study/NCT06161090)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 33
- **Lead Sponsor:** Keymed Biosciences Co.Ltd
- **Conditions:** Healthy
- **Start Date:** 2019-09-03
- **Completion Date:** 2020-01-13
- **CT.gov Last Update:** 2023-12-07

## Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** MALE
- **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.
```

## Arms

- **Group 75 mg** (EXPERIMENTAL) — CM310 Recombinant Humanized Monoclonal Antibody Injection
- **Group 150 mg** (EXPERIMENTAL) — CM310 Recombinant Humanized Monoclonal Antibody Injection
- **Group 300 mg** (EXPERIMENTAL) — CM310 Recombinant Humanized Monoclonal Antibody Injection
- **Group 600 mg** (EXPERIMENTAL) — CM310 Recombinant Humanized Monoclonal Antibody Injection
- **Placebo** (PLACEBO_COMPARATOR) — Placebo, Subcutaneous

## Interventions

- **CM310** (BIOLOGICAL) — CM310 injection
- **Placebo** (DRUG) — subcutaneous injection

## Primary Outcomes

- **Adverse event** _(time frame: up to Week 9)_ — Incidence of adverse events.

## Locations (1)

- PKUCare Luzhong Hospital, Zibo, China

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pkucare luzhong hospital|zibo||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06161090.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06161090*  
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