Health TrialsbyHealthPanel

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients

ConditionDiabetic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30+
SponsorAlebund Pharmaceuticals

About this trial

The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants, ≥30 years of age at the time of signing the informed consent form.

BMI (body mass index) 18-30 kg/m².

Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..

Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.

Disqualifiers

Chronic kidney disease other than type 2 diabetic kidney disease.

Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.

Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.

Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AP303 150μg

    Drug

    AP303 Tablet 150μg QD

  • Placebo 150μg

    Drug

    Placebo Tablet 150μg QD

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: AP303Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cmax

Maximum observed plasma concentration

Time frame
Day 1, Day 14
2

Tmax

Time to maximum observed plasma concentration

Time frame
Day 1, Day 14
3

AUC0-24h

Area under the plasma concentration versus time curve up to 24 hours

Time frame
Day 1
4

AUC0-last

Area under the plasma concentration versus time curve up to the last measurable concentration

Time frame
Day 1

Secondary outcomes

1

Fasting glucose

Change of fasting glucose

Time frame
Baseline, Days 6, 10, 14 and 28
2

Fasting lipid profile

Change of Triglyceride, HDL-C, LDL-C, Total cholesterol

Time frame
Baseline, Days 6, 10, 14 and 28
3

Serum creatinine

Change of serum creatinine

Time frame
Baseline, Days 6, 10, 14 and 28
4

eGFR

Change of estimated glomerular filtration rate

Time frame
Baseline, Days 6, 10, 14 and 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alebund Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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