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CompletedNCT05932888Updated Sep 21, 2023

Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects

A Phase 1 interventional study of QLM3003 and QLM3003 Placebo in Atopic Dermatitis, sponsored by Qilu Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.

Read the detailed description

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo ). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's enrollment of 40 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 195 studies on the registry; 117 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
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. Healthy adult subjects between 18-55 years of age (inclusive), male or female
  2. The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight not less than or equal to 50 kg, females of weight not less than or equal to 45 kg.
  3. Subjects have no sperm donation, egg donation plan, no pregnancy plan and voluntarily take effective contraceptive measures from 14 days before signing the informed consent form to 30 days after the last dose of investigational product;
  4. The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are allergic to the investigational product or its preparation ingredients, or have previous allergic diseases, history of drug allergy, history of skin allergy, or known to be hypersensitive;
  2. Patients with clinically relevant skin diseases that are contraindicated in the study or affect the assessment of the administration site at screening, including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, or other skin lesions, and a history of skin cancer;
  3. Skin conditions affecting the assessment of the study drug such as ulceration, injury, sunburn, redness and swelling, rash, or abnormal fever, tattoos, birthmarks, skin scars, skin perforations, skin infections on the skin of the target application area at screening and before administration, or disagreeing to removing the hair on the skin of this site;
  4. Pregnant or lactating women, and those who cannot use one or more non-drug contraceptive measures during the trial;
  5. Patients who have difficulty in collecting blood or cannot tolerate venipuncture, and have a history of fainting needle halo;
  6. Those who have special requirements for diet and cannot abide by the unified diet;
  7. Excessive consumption of tea, coffee or caffeinated beverages, or consumption of grapefruit, or xanthine-rich foods or beverages within 14 days before screening, or inability to stop consumption of xanthine-rich foods or beverages, or grapefruit or pomelo and products containing grapefruit or pomelo ingredients within 48 hours before dosing and during the trial;
  8. Patients who smoked more than 5 cigarettes or the same amount of tobacco daily for 3 months before screening and could not stop using any tobacco products during the trial;
  9. Regular drinkers within 6 months before screening, i.e., those who drank more than 14 units of alcohol per week or could not stop using any alcohol-containing products during the trial; or those who took any alcohol-containing products within 48 hours before the first dose, or those who tested positive for alcohol breath before randomization;
  10. Drug abusers or those who have used soft drugs within 3 months before screening or hard drugs within 1 year before screening or those who have positive drug abuse screening before randomization;
  11. Blood donation or massive blood loss, receiving blood transfusion or using blood products within 3 months before screening;
  12. Any surgical procedure within 30 days prior to Screening or planned during the study and within 30 days after the end of the study;
  13. Patients who have received any live vaccines within 30 days before screening or need to receive live vaccines during the study;
  14. Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days before screening;
  15. Patients who have taken any drug or health product within 14 days before screening;
  16. Patients who have participated in and used any drug or medical device clinical trials within 3 months before screening, or within 5 half-lives of other investigational drugs before screening;
  17. Patients with previous serious or clinically significant diseases or abnormalities at screening, including but not limited to cardiovascular system, nervous system, respiratory system, blood and lymphatic system, digestive system, immune system, liver, kidney, metabolism and bone system diseases or psychiatric diseases or history of malignant tumors;
  18. Abnormal vital signs or clinically significant abnormalities in physical examination, ECG and laboratory tests (subject to the judgment of the clinical study physician);
  19. Patients with active tuberculosis suggested by clinical symptoms, signs, laboratory tests or chest radiography at screening;
  20. Patients whose white blood cell count, neutrophil count, lymphocyte count or hemoglobin in blood routine examination exceed the normal reference range and have clinical significance judged by the investigator;
  21. May increase study-related risks, may interfere with interpretation of study results, or, in the judgment of the investigator, make the investigator and/or sponsor unsuitable for enrollment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    QLM3003

    QLM3003 Single dose

    Drug: QLM3003

  • Placebo comparator
    QLM3003 Placebo

    QLM3003 vehicle Single dose

    Drug: QLM3003 Placebo

Interventions

  • DrugQLM3003

    1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)

  • DrugQLM3003 Placebo

    1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)(matching corresponding study medication)

06

What researchers measure

Primary outcomes

  1. Incidence (severity and causality) of any local and systemic adverse events

    adverse events

    Time frame: 8 days

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of QLM3003

    Cmax

    Time frame: 8 days

  2. Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003

    AUC0-t

    Time frame: 8 days

  3. Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003

    AUC0-∞

    Time frame: 8 days

07

Study locations

1 site
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05932888
Responsible party
Sponsor
First posted
Jul 6, 2023
Start date
Jun 25, 2023
Primary completion
Aug 5, 2023
Completion
Aug 30, 2023
Last update
Sep 21, 2023

Study contacts

guoping Yang, doctor
study director · The Third Xiangya Hospital of Central South University

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 completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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