---
title: Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
nct_id: NCT01262794
overall_status: COMPLETED
phase: PHASE1
sponsor: UCB Pharma
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01262794.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01262794"
ct_last_update_post_date: 2011-09-27
last_seen_at: "2026-05-12T06:22:08.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

**Official Title:** A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males

**NCT ID:** [NCT01262794](https://clinicaltrials.gov/study/NCT01262794)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** UCB Pharma
- **Conditions:** Healthy Volunteers
- **Start Date:** 2010-11
- **Completion Date:** 2011-09
- **CT.gov Last Update:** 2011-09-27

## Brief Summary

To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 60 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy Japanese volunteers

Exclusion Criteria:

* Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
* Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
```

## Arms

- **CDP6038 0.3 mg/kg** (EXPERIMENTAL)
- **CDP6038 1 mg/kg** (EXPERIMENTAL)
- **CDP6038 3 mg/kg** (EXPERIMENTAL)
- **CDP6038 6 mg/kg** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **CDP6038** (BIOLOGICAL) — 100 mg/mL solution for injection, single dose
- **Placebo** (BIOLOGICAL) — 0.9% sodium chloride for injection Single-dose

## Primary Outcomes

- **Maximum drug concentration (Cmax)** _(time frame: Multiple sampling from 0 to 113 days following single dose)_
- **Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)** _(time frame: Multiple sampling from 0 to 113 days following single dose)_
- **Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)** _(time frame: Multiple sampling from 0 to 113 days following single dose)_
- **Apparent volume of distribution (Vz/F)** _(time frame: Multiple sampling from 0 to 113 days following single dose)_
- **Apparent total body clearance (CL/F)** _(time frame: Multiple sampling from 0 to 113 days following single dose)_
- **Terminal elimination half-life (T½)** _(time frame: Multiple sampling from 0 to 113 days following single dose)_

## Secondary Outcomes

- **PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects** _(time frame: Multiple sampling from 0 to 15 weeks following single dose)_
- **Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects** _(time frame: Multiple sampling from 0 to 15 weeks following single dose)_

## Locations (1)

- Guildford, Surrey, United Kingdom

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — 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)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — 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.|guildford|surrey|united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01262794.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01262794*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*