---
title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
nct_id: NCT01339182
overall_status: COMPLETED
phase: PHASE1
sponsor: Xiamen Amoytop Biotech Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01339182.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01339182"
ct_last_update_post_date: 2013-02-04
last_seen_at: "2026-05-12T06:11:02.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers

**Official Title:** A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers

**NCT ID:** [NCT01339182](https://clinicaltrials.gov/study/NCT01339182)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Xiamen Amoytop Biotech Co., Ltd.
- **Collaborators:** Peking Union Medical College Hospital
- **Conditions:** Healthy
- **Start Date:** 2011-01
- **Completion Date:** 2012-08
- **CT.gov Last Update:** 2013-02-04

## Brief Summary

This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male subjects
* Age(yr)between 18 and 45
* Body mass index(BMI)between 20 and 28
* sign informed consent

Exclusion Criteria:

* Known hypersensitivity to somatropin or any other components of the study drug
* Organic lesion in heart, liver, kidney or any other major organs
* History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
* Alcoholic, smokers or drug abusers
* Blood donation, or massive blood loss due to injury or surgery within 3 months
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
```

## Arms

- **Pegylated-Somatropin, 10mcg/kg** (EXPERIMENTAL)
- **Pegylated-Somatropin, 30mcg/kg** (EXPERIMENTAL)
- **Pegylated-Somatropin, 60mcg/kg** (EXPERIMENTAL)
- **Pegylated-Somatropin, 120mcg/kg** (EXPERIMENTAL)
- **Pegylated-Somatropin, 200mcg/kg** (EXPERIMENTAL)

## Interventions

- **Pegylated-Somatropin** (DRUG) — Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg.
- **YPEG-Somatropin** (DRUG) — Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg.
- **YPEG-Somatropin** (DRUG) — Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg.
- **YPEG-Somatropin** (DRUG) — Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg.
- **YPEG-Somatropin** (DRUG) — Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg.

## Primary Outcomes

- **Measurement of the IGF-1 levels for pharmacodynamics study** _(time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug)_

## Secondary Outcomes

- **Measuring the drug levels in blood samples** _(time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug)_
- **Measurement of IGFBP-3 levels for pharmacodynamic study** _(time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug)_

## Locations (1)

- Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `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)_
- `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)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peking union medical college hospital|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01339182*  
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