---
title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
nct_id: NCT05147259
overall_status: UNKNOWN
phase: PHASE1
sponsor: Jiangsu HengRui Medicine Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Diabetes in Adults
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05147259.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05147259"
ct_last_update_post_date: 2021-12-07
last_seen_at: "2026-05-12T06:12:26.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

**Official Title:** A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

**NCT ID:** [NCT05147259](https://clinicaltrials.gov/study/NCT05147259)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Jiangsu HengRui Medicine Co., Ltd.
- **Conditions:** Diabetes in Adults
- **Start Date:** 2021-11-29
- **Completion Date:** 2022-02-16
- **CT.gov Last Update:** 2021-12-07

## Brief Summary

The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Male or female aged 18-55 years(both inclusive) at the time of signing informed consent
2. Body mass index 18.0-26.0kg/m2(both inclusive)
3. Body weight ≥50.0kg(male),≥45.0kg(female)
4. Fasting serum/plasma glucose \<6.1mmol/L

Exclusion Criteria:

1. Known or suspected of being allergic to any ingredient in the study drug.
2. Participated in any drug or medical device-related clinical trial within 3 months before screening.
3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration
4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.
5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.
```

## Arms

- **Cohort one: Low dose** (EXPERIMENTAL) — Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
- **Cohort two: Medium dose** (EXPERIMENTAL) — Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
- **Cohort three: high dose** (EXPERIMENTAL) — Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively

## Interventions

- **HR011408 injection** (DRUG) — Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.

## Primary Outcomes

- **Incidence and severity of adverse events (AEs)** _(time frame: from Day1 to Day15)_ — The incidence of adverse events will be collected and the safety of HR011408 will be assessed
- **Area under the concentration-time curve (AUC)** _(time frame: from 0 to 10 hours after dose administration)_ — Area under the concentration-time curve (AUC)
- **Maximum observed concentration (Cmax)** _(time frame: from 0 to 10 hours after dose administration)_ — Maximum observed concentration (Cmax)
- **Time to maximum observed concentration (Tmax)** _(time frame: from 0 to 10 hours after dose administration)_ — Time to maximum observed concentration (Tmax)
- **Elimination half-life (t1/2)** _(time frame: from 0 to 10 hours after dose administration)_ — Elimination half-life (t1/2)
- **Time to 50% maximum observed concentration (time to 50% Cmax)** _(time frame: from 0 to 10 hours after dose administration)_ — Time to 50% maximum observed concentration (time to 50% Cmax)
- **Onset of appearance** _(time frame: from 0 to 10 hours after dose administration)_ — First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)

## Secondary Outcomes

- **Assessment of development of Anti-drug Antibodies (ADAs)** _(time frame: from Day1 to Day15 after dose administration)_

## 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)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05147259.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05147259*  
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