AzTrials
AzTrials

Overweight and ObesityPhase 1NCT06490263

the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids in Human

A Phase 1 study testing Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects, Mulberry Twig Alkaloids Tablets with single dose in healthy subjects and Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects in people with Overweight and Obesity and Healthy, run by Beijing Wehand-Bio Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy ，overweight and obesity subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity, Healthy
What is being tested?
Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects, Mulberry Twig Alkaloids Tablets with single dose in healthy subjects and Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
13 May 2024to 4 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Healthy volunteers,Body mass index between 18.5 and 24 kilogram per meter square (kg/m/m²) 18.5 inclusive). For obese or overweight participants, BMI must be at least 24 kg/m², with a requirement for some participants to have a BMI of 28 kg/m² or higher.
  • Subjects should have no history or current evidence of heart, liver, kidney, gastrointestinal, neurological, respiratory, psychiatric disorders, or metabolic abnormalities that the investigator deems requiring treatment. Vital signs, physical examination, laboratory tests, electrocardiogram (ECG), chest X-ray, abdominal ultrasound results should either be normal or show abnormalities that are deemed clinically insignificant by the attending physician.
  • Participants must not plan to become pregnant for six months following the last dose of the study drug, agree to use effective contraception to prevent pregnancy or causing pregnancy in their partner, and have no intention to donate sperm or eggs during the study period.
  • Individuals must comprehend the procedures and methods of this clinical trial, voluntarily participate and personally sign the informed consent form, demonstrating willingness to adhere to the protocol requirements and cooperate in providing biological samples according to the scheduled plan for testing.

Who cannot join

  • Secondary obesity, including conditions such as Cushing's syndrome, hypogonadism, growth hormone deficiency, hypothalamic disorders, pseudohypoparathyroidism, insulinoma, and hypothyroidism;
  • Presence of diseases exacerbating gastrointestinal bloating (e.g., Roemheld syndrome, severe hernias, intestinal obstruction, and peptic ulcers) or chronic gastrointestinal dysfunction with evident digestion and absorption disorders;
  • Diagnosis of diabetes mellitus according to the diagnostic guidelines set forth by the World Health Organization (WHO);
  • History of atopic allergic diseases or known allergies to the investigational product, its excipients, or similar medications;
  • History of orthostatic hypotension, syncope, transient loss of vision, or severe episodes of hypoglycemia;
  • Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (anti-HCV), Human Immunodeficiency Virus antibody (anti-HIV), or Treponema pallidum antibody (TP-Ab).
Show all 20Show fewer
  • Participants with a history of drug abuse within 12 months prior to screening or those with positive urine tests for prohibited drugs;
  • Individuals with a history of alcohol abuse or frequent consumption (more than 14 units of alcohol per week, with 1 unit approximately equivalent to 360ml of beer, 45ml of 40% alcohol content spirits, or 150ml of wine) within 6 months prior to screening, or those with a positive breathalyzer test at screening/baseline, or unwillingness to abstain from alcohol during the study;
  • Those who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or unwilling to quit smoking during the study;
  • Individuals who donated blood (including apheresis) or experienced significant blood loss exceeding 400ml within 3 months prior to screening, received a blood transfusion or used blood products;
  • Participants who have taken part in any clinical trial within 3 months prior to screening, or plan to participate in another trial during or within 1 month after this study;
  • Individuals with a clinically significant surgical history as judged by the investigator within the screening period, or planning elective surgery between the dosing period and up to 1 month post-dosing;
  • Those who used any prescription drugs, traditional Chinese medicine, or herbal remedies within 4 weeks prior to dosing, or within 5 half-lives of any prescribed medication (whichever is longer), and/or consumed over-the-counter drugs, health supplements (excluding routine vitamin supplementation) within 2 weeks prior to dosing; those vaccinated within 4 weeks before dosing;
  • Participants who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (≥8 cups, where 1 cup = 250ml) within 2 weeks prior to dosing, or who refuse to abstain from grapefruit juice or any food and drink containing alcohol and xanthines (including chocolate, tea, coffee, cola, etc.) for 48 hours before dosing and throughout the study;
  • Individuals who have been on a diet or undergone weight loss treatments within a month prior to dosing, or have made significant changes to their lifestyle habits (diet, exercise, etc.);
  • Pregnant or breastfeeding women, or those of childbearing potential who had unprotected sexual intercourse within 30 days prior to screening;
  • Participants with difficult venous access, poor peripheral venous condition, or unable to tolerate multiple blood draws, or have any contraindications to blood sampling;
  • Unwillingness or inability to follow lifestyle guidance as described in the study protocol;
  • Participants who are directly involved in this trial or are relatives (spouse, parents/legal guardians, siblings, or children) of personnel from the research center or the sponsor;
  • As judged by the investigator, individuals with conditions that may affect drug absorption, distribution, metabolism, excretion, or safety assessment, or that may reduce compliance, or those whom the investigator deems to pose a safety risk by participating in the study, as well as any other circumstances rendering them unsuitable for this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: A Phase I Clinical Trial in Healthy and Overweight/Obese Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids

This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy ，overweight and obesity subjects.

Read the detailed description

This is a Phase I clinical trial of safety, tolerability and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy and overweight or obesity subjects. This trial is divided into three parts:

The first part study aims to compare the pharmacokinetics characteristics of WH006 chewing with the first bite of a standardized meal or swallowing after a standardized meal in healthy subjects.

The second part study aims to investigate the safety, tolerability and pharmacokinetics of single ascending doses of WH006 in healthy subjects.

The third part study aims to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of WH006 in both healthy participants and overweight or obese subjects.

Being tested
Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects, Mulberry Twig Alkaloids Tablets with single dose in healthy subjects, Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects, Mulberry Twig Alkaloids Tablets with multiple dose in overweight or obese subjects
Keywords
Obesity Management, Hypoglycemic Agents
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjectsDrug

    Also called WH006

    Part One: Administered by chewing with meals or swallowing after meals, with a dosage of 126 milligrams, given as a single dose only.

  • Mulberry Twig Alkaloids Tablets with single dose in healthy subjectsDrug

    Also called WH006

    Parts Two: Administered by swallowing after meals with four distinct dosage groups.

  • Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjectsDrug

    Also called WH006

    Part Three: Administered by swallowing after meals with two distinct dosage groups, taken three times daily.

  • Mulberry Twig Alkaloids Tablets with multiple dose in overweight or obese subjectsDrug

    Also called WH006

    Part Three: Administered by swallowing after meals with two distinct dosage groups, taken three times daily.

Study groups in NCT06490263
Study groupRoleWhat they receive
chewing or swallowing with single dose of WH006 in healthy subjects(Part One)ExperimentalAdministered by chewing with meals or swallowing after meals, with a dosage of 126 milligrams, given as a single dose only in healthy subjects.
Receives: Drug: Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects
single dose ascending of WH006 in healthy subjects (Part Two)ExperimentalAdministered by swallowing after meals with a single dose, four dose groups were performed sequentially in healthy subjects.
Receives: Drug: Mulberry Twig Alkaloids Tablets with single dose in healthy subjects
multiple dose ascending of WH006 in healthy subjects (Part Three)ExperimentalAdministered by swallowing after meals, taken three times daily; two dose groups were performed sequentially in healthy subjects.
Receives: Drug: Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects
multiple dose ascending of WH006 in overweight or obese subjects(Part Three)ExperimentalAdministered by swallowing after meals, taken three times daily; two dose groups were performed sequentially in overweight or obese subjects.
Receives: Drug: Mulberry Twig Alkaloids Tablets with multiple dose in overweight or obese subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events(Part Two and Part Three)

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported.

    Measured: Part Two: From Day 1 to Day 4; Part Three: From Day 1 to Day 12.

  2. To compare the Cmax of chewing or swallowing of WH006 with single dose(Part One)

    To measure the peak drug concentration of Mulberry Twig Alkaloids（1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA））with the first bite of a standardized meal or swallowing after a standardized meal

    Measured: Part One: From Day 1 to Day 2, Day 5 to Day 6;

  3. To compare the AUC0-32h of chewing or swallowing of WH006 with single dose(Part One)

    To measure the area under the concentration-time curve from time zero to time 32 hours of Mulberry Twig Alkaloids（1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA））with the first bite of a standardized meal or swallowing after a standardized meal

    Measured: Part One: From Day 1 to Day 2, Day 5 to Day 6;

  4. To compare the AUC0-inf of chewing or swallowing of WH006 with single dose(Part One)

    To measure the area under the concentration time curve from time zero to time infinity of Mulberry Twig Alkaloids（1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA））with the first bite of a standardized meal or swallowing after a standardized meal

    Measured: Part One: From Day 1 to Day 2, Day 5 to Day 6;

Secondary outcomes (8)

  1. To determine the Cmax of WH006 with escalating single dose in healthy subjects(Part Two and Part Three)

    To measure the peak drug concentration of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating single dose in healthy subjects.

    Measured: Part Two: From Day 1 to Day 2;Part Three: From Day 1 to Day 2, Day 8 to Day 10.

  2. To determine the AUC0-48 of WH006 with escalating single dose in healthy subjects(Part Two and Part Three)

    To measure the area under the concentration-time curve from time zero to time 48 hours of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating single dose in healthy subjects.

    Measured: Part Two: From Day 1 to Day 2;Part Three: From Day 1 to Day 2, Day 8 to Day 10.

  3. To determine the AUC0-inf of WH006 with escalating single dose in healthy subjects(Part Two and Part Three)

    To measure the area under the concentration-time curve from time zero to time infinity of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating single dose in healthy subjects.

    Measured: Part Two: From Day 1 to Day 2;Part Three: From Day 1 to Day 2, Day 8 to Day 10.

  4. To determine the Cmax,ss of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three)

    To measure the maximum concentration at steady state of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating multiple dose in healthy and overweight or obese subjects.

    Measured: Part Three: From Day 1 to Day 10;

  5. To determine the Cmin,ss of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three)

    To measure the trough plasma concentration at steady state of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating multiple dose in healthy and overweight or obese subjects.

    Measured: Part Three: From Day 1 to Day 10;

  6. To determine the Cav,ss of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three)

    To measure the average concentration at steady state of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating multiple dose in healthy and overweight or obese subjects.

    Measured: Part Three: From Day 1 to Day 10;

  7. To determine the AUC0-tau of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three)

    To measure the area under the concentration-time curve from time zero to 5 hours, 14 hours and 24hours of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating multiple dose in healthy and overweight or obese subjects.

    Measured: Part Three: From Day 1 to Day 10;

  8. To determine the Rac of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three)

    To calculate the Rac (Cmax), Rac (AUC0-5),the Rac (AUC0-14), the Rac (AUC0-24), the Rac (AUC0-inf) with the ratio of D8 parameters and D1 parameters of Mulberry Twig Alkaloids(1-deoxynojirimycin（DNJ）, 1,4-dideoxy-1,4-imino-D-arabinitol（DAB）, Fagomine （FA）) with escalating multiple dose in healthy and overweight or obese subjects.

    Measured: Part Three: From Day 1 to Day 10;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2024
  2. Study start13 May 2024
  3. Primary completion19 Oct 2024
  4. Study completion4 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06490263
Sponsor's protocol ID
WH006-I-101
Status last verified
Jun 2024
First submitted
18 Jun 2024
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects, Mulberry Twig Alkaloids Tablets with single dose in healthy subjects and Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects in people with Overweight and Obesity and Healthy, run by Beijing Wehand-Bio Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events(Part Two and Part Three) (time frame: Part Two: From Day 1 to Day 4; Part Three: From Day 1 to Day 12.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06490263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in