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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWX205

8. juni 2026 oppdatert av: Shanghai Minwei Biotechnology Co., Ltd

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MWX205 Injection in Adult Participants With Dyslipidemia

This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia).

Researchers will check if a single dose of MWX205 is safe and how the body reacts to it. They will also measure how quickly the drug enters the bloodstream and how long it stays in the body, and compare it with a placebo (inactive treatment).

The study will help decide the right dose and understand how this medicine could be used in future treatments.

The main questions this study aims to answer are:

  1. Is MWX205 safe after a single dose?
  2. How does the body process MWX205?
  3. Does MWX205 show any effect on the body related to cholesterol levels?

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MWX205 Injection will be assessed in adult participants with dyslipidemia.

Overall, 37 participants will be enrolled and assigned to 5 sequential cohorts (Cohorts 1 through 5).

Cohort 1 will enroll 5 participants and be randomized 3:2 to receive a single dose of MWX205 or placebo (3 participants receiving MWX205 and 2 receiving a placebo).

Cohorts 2 to 5 will be comprised of 8 participants per Cohort and randomized 3:1 to receive a single dose of MWX205 or placebo, respectively (6 participants receiving MWX205 Injection and 2 receiving a placebo).

Dosing in each cohort will be such that 2 participants (1 MWX205 Injection and 1 placebo) will be administered at least 24 hours before the remaining 3 participants (the first cohort) or 6 participants (cohorts 2-5). After dosing the first 2 participants on a separate day, a minimum of a 5-minute dosing interval for the remaining 3 participants (the first cohort), or 6 participants (cohorts 2-5) in the following cohort, is considered acceptable.

Continuation to dose the remaining 3 participants (Cohort 1) or 6 participants (Cohorts 2-5) will be at the investigator's discretion.

Each participant will participate in 1 cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 8.

Studietype

Intervensjonell

Registrering (Antatt)

37

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

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

Nei

Beskrivelse

Inclusion Criteria:

  1. Adult participants with dyslipidemia will be enrolled in this study.
  2. The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
  3. Participants must have fasting triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) and less than 500 mg/dL (5.7 mmol/L), and LDL-C greater than or equal to 70 mg/dL (1.8 mmol/L) at pre-screening and confirmation within 7 days before randomization.
  4. Have a body mass index within the range 18.5 to 40.0 kg/m2 (inclusive), with no plans to significantly alter diet or BMI over the course of study.
  5. Females of childbearing potential and males who are not surgically sterile (> 90 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 6 months after the administration, OR females of non-reproductive potential

Exclusion Criteria:

  1. Positive pregnancy test or lactating female participant.
  2. Systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm at screening.
  3. QTcF over 450 ms at screening.
  4. Consume more than 7 units for women or 14 units for men of alcohol per week within 8 weeks prior to screening (1 unit = 285 mL of beer 3.5%, 75 mL of wine 13.5%, or 25 mL of distilled alcohol 40%).
  5. Participants with established coronary artery disease, peripheral arterial disease, prior stroke, or other clinically significant atherosclerotic cardiovascular disease (such as stent placement or heart bypass, unstable angina or last known ejection fraction of <50%).
  6. History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc.), or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with the evaluation of injection reaction.
  7. Have taken any prescription medications that are specifically indicated for lowering serum TGs (e.g., fibric acid derivatives, niacin, and omega-3 fatty acids [>1 g/day]) or medications that interfere with absorption of dietary cholesterol or fats (e.g., bile acid sequestrants, orlistat) within 2 months prior to screening.
  8. Have received treatment with any liver-targeted siRNA therapy or ASO (Antisense Oligonucleotide) within12 months prior to screening.
  9. Use of ANGPTL3 or PCSK9-inhibiting monoclonal antibodies within 90 days prior to screening.
  10. Use of systemic glucocorticoid therapy for more than 14 consecutive days in the past year, or any glucocorticoid therapy (excluding topical, intra-ocular, intra-articular, intranasal, or inhaled preparations) within 1 month before screening.

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MWX205
Strength: 1ml: 200 mg Proposed dose levels for SAD study: 50, 200, 400, 800, and 1200 mg Administration: subcutaneous injection, recommended in the abdomen.
Each vial contains 200mg of MWX205 small nucleic acid, with water for injection as the solvent. The excipient, including sodium hydroxide and/or hydrochloric acid, may be added to adjust the pH to 6.5±0.2.
Placebo komparator: Placebo
Administration: subcutaneous injection, recommended in the abdomen.
Matchende placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of TEAEs
Tidsramme: From Day 1 to Day 86
From Day 1 to Day 86
Incidence of SAEs
Tidsramme: From Day 1 to Day 86
From Day 1 to Day 86
Number of participants with abnormal vital signs
Tidsramme: From Day 1 to Day 86
Vital signs include tympanic body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate
From Day 1 to Day 86
Number of participants with abnormal Physical examination findings
Tidsramme: From Day 1 to Day 337
Complete physical examinations include general appearance, mouth/dental (if required), neck (including thyroid & nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, other
From Day 1 to Day 337
Number of participants with abnormal ECG readings
Tidsramme: From Day 1 to Day 337
12 Lead ECG: Triplicate readings to be taken within 2 to 5 minutes of each other. ECGs are to be taken after the participant has rested in the supine position for ≥ 5 minutes
From Day 1 to Day 337

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)
Tidsramme: Day 1, Day 2, Day 3
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Day 1, Day 2, Day 3
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
Tidsramme: Day 1, Day 2, Day 3
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Day 1, Day 2, Day 3
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
Tidsramme: Day 1, Day 2, Day 3
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Day 1, Day 2, Day 3
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
Tidsramme: Day 1, Day 2, Day 3
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Day 1, Day 2, Day 3
Urine PK parameters- Fe (dose fraction of the drug in its original form excreted in urine after administration)
Tidsramme: Day 1, Day 2, Day 3
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Day 1, Day 2, Day 3
Urine PK parameters- Ae (cumulative excretion of the drug's original form in urine)
Tidsramme: Day 1, Day 2, Day 3
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Day 1, Day 2, Day 3

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Mohd Naguib bin Mohd Yunos, Dr., Veritus Research

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 (Antatt)

22. juni 2026

Primær fullføring (Antatt)

26. oktober 2026

Studiet fullført (Antatt)

8. november 2027

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • MWX205-101

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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