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A Phase I Clinical Trial to Evaluate CMS-F021 Following Single and Multiple Doses in Healthy Participants

25. august 2026 oppdatert av: Dermavon Holdings Limited

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, PK Characteristics of CMS-F021 Following Single and Multiple Topical Administrations in Healthy Participants

"This study is a first-in-human (FIH) trial of CMS-F021 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics of CMS-F021 gel following single and multiple topical administrations in healthy Chinese adult participants.

Both parts of the study are designed as randomized, double-blind, placebo controlled, sequential cohort trials. Part 1 SAD plans to include 5 dose cohorts,with 8 participants per cohort (6 receiving CMS-F021 and 2 receiving placebo),for a total of 40 participants. Part 2 MAD plans to include 4 dose cohorts, with 8 participants per cohort (6 receiving CMS-F021 and 2 receiving placebo), for a total of 32 participants."

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

72

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Beijing, Kina
        • Rekruttering
        • Beijing Jishuitan Hospital,Capital Medical University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

Participants must meet all of the following eligibility criteria to be enrolled in this study:

  1. Voluntarily participate in this study and sign the informed consent form, able to understand and comply with all requirements and restrictions of this study, and capable of completing the study according to the protocol;
  2. Age between 18 and 55 years (inclusive of boundary values, based on the date of signing the informed consent form), male or female;
  3. Body mass index (BMI) within the range of 19.0-26.0 kg/m² (inclusive of boundary values) at screening, with female weight ≥ 45.0 kg and male weight ≥ 50.0 kg;
  4. Participants with reproductive potential (including their partners) must have no plans for pregnancy, egg donation, or sperm donation from the date of signing the informed consent form until 3 months after the last dose of study medication, and must strictly adhere to contraceptive measures during this period.

Exclusion Criteria:

Any participant meeting any of the following exclusion criteria will not be eligible for enrollment:

  1. Those with a history of allergy or allergic constitution;
  2. Abnormal vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), or 12-lead ECG findings at screening, judged by the investigator to have clinical significance;
  3. History or clinical manifestations of significant diseases involving cardiovascular, respiratory, digestive, urinary/reproductive, hematologic, endocrine/metabolic, rheumatologic/immunologic, neurological/psychiatric, or musculoskeletal systems requiring medication and/or other treatments (including dietary restrictions and physical therapy), or considered by the investigator unsuitable for participation in this study; 4)Those with a history of severe skin diseases;

5) Evidence of current acute skin infection, or history of recurrent or chronic severe skin infections; 6) Researchers believe there may be some skin conditions that could interfere with skin assessment; 7) Use of any prescription or non-prescription medication (including herbal medicines, vitamins, minerals, and dietary supplements) within 2 weeks before dosing or within at least five half-lives (whichever is longer); 8) Participation in any other clinical trial involving drugs or medical devices within 3 months prior to screening, or planning to participate in such trials during this study, or still within the 5 half-life window of a previous investigational agent (whichever is longer); 9) History of drug abuse within the past 6 months, or positive results in any drug abuse screening test; 10) Weekly alcohol consumption exceeding 14 units within the past 3 months (1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits), or positive alcohol breath test result, or inability to abstain from alcohol during the study; 11) Average daily smoking of more than 5 cigarettes within the past 3 months, or inability to discontinue use of any tobacco products during the study; 12) Pregnant or breast feeding females; 13) Difficulty with venipuncture (e.g., history of needle phobia or fainting due to blood draw), or poor venous access deemed unsuitable by the investigator; 14) Blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of blood transfusion or blood products, or plan to donate blood during the study period; 15) Any other condition determined by the investigator to be unsuitable for participation in this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: "Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant
"Drug: CMS-F021 Gel healthy participant"
Single Dose
Placebo komparator: "Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par
"Drug: CMS-F021 Placebo Gel healthy participant"
Single Dose
Aktiv komparator: "Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa
"Drug: CMS-F021 Gel healthy participant"
Multiple Dose
Placebo komparator: "Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan
"Drug: CMS-F021 Placebo Gel healthy participant"
Multiple Dose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
Tidsramme: through study completion,an average of 4 days or 10 days
Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.
through study completion,an average of 4 days or 10 days
Incidence rate of abnormal findings in comprehensive systemic physical examination
Tidsramme: through study completion,an average of 4 days or 10 days
Record abnormal physical examination findings by system (cardiovascular, respiratory, digestive, etc.), summarize the number and incidence rate of abnormalities in each system, and categorize them as related or unrelated to the study drug.
through study completion,an average of 4 days or 10 days
Hematology, biochemistry, urinalysis ,and Coagulation Profilelaboratory test indicators
Tidsramme: through study completion,an average of 4 days or 10days
The tests include complete blood count (WBC, RBC, Hb, etc.), blood biochemistry (ALT, AST, Cr, etc.), urinalysis ,and Coagulation Profile; changes from baseline were calculated, and the incidence of abnormal values was summarized according to CTCAE 6.0 grading.
through study completion,an average of 4 days or 10days
12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
Tidsramme: through study completion,an average of 4 days or 10days
Collected using standard 12-lead ECG equipment,with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities summarized.
through study completion,an average of 4 days or 10days
Skin Irritation Score
Tidsramme: through study completion,an average of 4 days or 10days
Skin reactions will be assessed using the skin irritation scoring scale specified in the FDA and CDE guidance documents, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs and Technical Guidance for Clinical Trials Evaluating Adhesion and Irritation/Sensitization of Transdermal and Topical Delivery Systems for Chemical Generic Drugs (Trial Implementation).
through study completion,an average of 4 days or 10days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum plasma drug concentration (Cmax)
Tidsramme: Through 48 hours post-dose
Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA)
Through 48 hours post-dose
Tmax
Tidsramme: Through 48 hours post-dose
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration
Through 48 hours post-dose
Area under the curve (AUC0-t)
Tidsramme: Through 48 hours post-dose
Calculate the area under the concentration-time curve from time of administration (0 h) to the last quantifiable concentration time point (t) using non-compartmental analysis (NCA)
Through 48 hours post-dose

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: MEIXIA WANG, Beijing Jishuitan Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. juli 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

30. juli 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • F021-01-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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