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Not yet recruitingNCT07918898Updated Nov 5, 2026

Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart

A Phase 1 interventional study of GZR101 80 Injection and GZR33 Injection in Healthy Participants, sponsored by Gan & Lee Pharmaceuticals.. Not yet recruiting. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Gan & Lee Pharmaceuticals. · Phase 1, Interventional, and Other

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

This trial is conducted in China. This study will be conducted to evaluate pharmacokinetic/pharmacodynamic characteristics and safety of single administration of GZR101-80 Injection with separately injected, simultaneous doses of GZR33 Injection and Insulin Aspart in healthy participants

02

Conditions studied

  • Healthy Participants

Keywords

  • Healthy Participants
  • Pharmacokinetic
  • Pharmacodynamic
03

In context

Lead sponsor

Gan & Lee Pharmaceuticals. is the lead sponsor of 29 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily signed the form (ICF), was amenable to subcutaneous injection, had fully understood the study content, procedures and potential adverse reactions, and was able to comply with the and restrictions specified in this protocol.
  2. Male, aged between 18 and 45 years (both inclusive) at the time of ICF.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with allergic diathesis, or a medical history of allergic diseases such as bronchial asthma and eczema.
  2. Subjects with abnormal findings for surface antigen, antibody, antigen and antibody combined assay, or treponema pallidum antibody test at screening.
  3. Subjects who donated blood or had blood loss of ≥ 400 mL within 6 months prior to screening, or intend to donate blood during the study.
  4. Subjects with a history of drug abuse prior to screening, or with a positive drug abuse screening result at screening.
  5. Subjects with an average daily cigarette consumption of ≥5 cigarettes within 3 months prior to screening, or those who refuse to abstain from smoking throughout the study period.
  6. Subjects with a history of vasovagal syncope related to needles or blood, difficulty in blood collection, or intolerance to venipuncture for blood sampling.
  7. Subjects who are employees of the investigator or the study site, or family members of such employees or investigators, or subjects whom the investigator considers otherwise unsuitable for participation in this study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    GZR101 80 Injection

    Drug: GZR101 80 Injection

  • Experimental
    GZR33 Injection + Insulin Aspart Injection

    Drug: GZR33 Injection · Drug: Insulin Aspart Injection

Interventions

06

What researchers measure

Primary outcomes

  1. AUCIAsp,0-6h

    Time frame: 0-6 hours after dosing

  2. AUC GZR33, 0-24h

    Time frame: 0-24 hours after dosing

Secondary outcomes

  1. AUCGZR33, 0-∞

    Time frame: 0-120 hours after dosing

  2. AUC IAsp, 0-∞

    Time frame: 0-120 hours after dosing

  3. Incidence of adverse events

    Time frame: 0-120 hours after dosing

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Feb 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 5, 2026
StartEst.
Oct 29, 2026
Primary completionEst.
Feb 2, 2027
CompletionEst.
Feb 2, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07918898
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Oct 29, 2026 (estimated)
Primary completion
Feb 2, 2027 (estimated)
Completion
Feb 2, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Yunhong Wu
Contact
YunhongWu@ganlee.com
010-56456739

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: GZR33 · Insulin Aspart

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