The Safety and Tolerability of Alkaloids from Alstonia scholaris Leaves in Healthy Chinese Volunteers

The Safety and Tolerability of Alkaloids from Alstonia scholaris Leaves in Healthy Chinese Volunteers: a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038081

Enrollment

Unknown

Registered

2020-09-09

Start date

2013-01-02

Completion date

Unknown

Last updated

2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and tolerability

Interventions

Single-dose 1:8 mg

Single-dose 2:40 mg

Single-dose 3:120 mg

Single-dose 3:240 mg

Single-dise 4:360 mg

Single-dose 5:480 mg

Placebo of single-dose:Placebo

Multiple-dose 1:40 mg

Multiple-dose 2:120 mg

Placebo of multple-dose:Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants should be healthy male and female (male/female: half/half), non-smokers, and ages in the range of 18 to 45 years, with body mass index (BMI) of 19 to 24 kg/m2 and minimum body weight of 45 kg for females and 50 kg for males. All these indexes including physical, biochemical, blood routine test, ECG and upper abdominal color ultrasound examination were normal. Additionally, eligible female subjects were required not to be pregnant, lactating, or of childbearing potential. Subjects voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. A history of clinically diagnosed disease in circulatory, respiratory, digestive, urinary, hematological, endocrine/metabolic, neurologic, immunological system, or infectious and psychiatric illness; 2. Subjects with seropositive findings for human immunodeficiency virus, hepatitis B virus surface antigen, or anti-hepatitis C virus antibody; 3. Subjects with drug allergy history or allergic constitution; 4. Subjects who received any other medicine within 2 weeks before dosing; 5. Subjects participated in any clinical trial within 1 month before dosing; 6. A history of drug or alcohol abuse, or any condition that could interfere with absorption, distribution, metabolism and excretion of drugs; 7. Female subjects who were about to become pregnant or breast-feeding during the trial; 8. Subjects who were considered unsuitable for inclusion by researcher.

Design outcomes

Primary

Measure	Time frame
Biochemistry examination;Hematology;Urinalysis;ECG examination;Upper abdominal Doppler ultrasonography;Vital signs and physical examination;	—

Secondary

Measure	Time frame
Stool guaiac test;	—

Countries

China

Contacts

Public ContactXiaodong Luo

Kunming Institute of Botany, Chinese Academy of Sciences

xdluo@mail.kib.ac.cn+86 13888333553

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026