---
title: A Bioequivalence Study of Two Different PEG-rhGH Preparations.
nct_id: NCT06331026
overall_status: COMPLETED
phase: PHASE1
sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Pediatric Growth Hormone Deficiency (PGHD)
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06331026.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06331026"
ct_last_update_post_date: 2024-11-08
last_seen_at: "2026-05-12T07:33:07.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Bioequivalence Study of Two Different PEG-rhGH Preparations.

**Official Title:** A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults

**NCT ID:** [NCT06331026](https://clinicaltrials.gov/study/NCT06331026)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 87
- **Lead Sponsor:** Changchun GeneScience Pharmaceutical Co., Ltd.
- **Conditions:** Pediatric Growth Hormone Deficiency (PGHD)
- **Start Date:** 2024-04-09
- **Completion Date:** 2024-08-28
- **CT.gov Last Update:** 2024-11-08

## Brief Summary

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

## Eligibility

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

```
Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
```

## Arms

- **TRR** (EXPERIMENTAL) — Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R)
- **RTR** (EXPERIMENTAL) — Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
- **RRT** (EXPERIMENTAL) — Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T)

## Interventions

- **PEG-rhGH with new preparation (T)** (DRUG) — A single subcutaneous injection of PEG-rhGH with new preparation
- **PEG-rhGH with present preparation (R)** (DRUG) — A single subcutaneous injection of PEG-rhGH with present preparation

## Primary Outcomes

- **Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation** _(time frame: 0 hours -192 hours post-administration)_
- **Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation** _(time frame: 0 hours -192 hours post-administration)_
- **Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation** _(time frame: 0 hours -192hours post-administration)_

## Secondary Outcomes

- **Safety and tolerability（Number of participants with treatment-related adverse events）** _(time frame: up to approximately 83 days)_

## Locations (1)

- Chengdu Xinhua Hospital, Chengdu, Sichuan, China

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — 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)_
- `eligibility.minAge` — 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.chengdu xinhua hospital|chengdu|sichuan|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06331026*  
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