BB-101 for Treatment of Diabetic Lower Leg and Foot Ulcers

NCT03888053 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BB-101-001A
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 6

Brief Summary

This is a randomized, double-blind, placebo-controlled, sequential dose escalation study in diabetic subjects with a diabetic lower leg or foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (8)

• Incidence and severity of local reactions

  To assess the incidence of local reactions for target ulcer and surrounding area and record the severity

  6 weeks

• Incidence and severity of adverse events

  To assess the incidence of adverse events and record the severity

  6 weeks

• Incidence of clinical laboratory abnormalities

  To assess the incidence of clinical laboratory abnormalities

  6 weeks

• Change from baseline in ECG

  To assess the change of baseline in ECG

  6 weeks

• Change from baseline in blood pressure

  To assess the change of baseline in in blood pressure

  6 weeks

• Change from baseline in heart rate

  To assess the change of baseline in heart rate

  6 weeks

• Change from baseline in body temperature

  To assess the change of baseline in body temperature

  6 weeks

• Presence of anti-BB-101 antibodies

  To assess the immunogenecity for BB-101

  6 weeks

Secondary Outcomes (2)

• Proportion of subjects with target ulcer that heals within the 4-week treatment period

  4 weeks

• To evaluate plasma concentration of BB-101

  4 weeks

Study Arms (2)

BB-101 Treatment Arm

ACTIVE COMPARATOR

BB-101 liquid formulation concentration of 2 µg/mL or 20 µg/mL will be applied on the target lower leg or foot ulcer once a day for 4 consecutive weeks.

Biological: BB-101

Placebo Arm

PLACEBO COMPARATOR

Placebo will be applied on the target lower leg or foot ulcer once a day for 4 consecutive weeks.

Biological: BB-101

Interventions

BB-101 BIOLOGICAL

Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo.

BB-101 Treatment Arm; Placebo Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 20 years of age and older.
• Type 1 or type 2 diabetes mellitus.
• Glycosylated hemoglobin (HbA1c) of ≤12%.
• A target ulcer on the lower leg or foot that meets the following criteria at screening:
• located below knees,
• Area of 0.5 - 20.0 cm\^2 following sharp debridement , as measured at Visit 1 and confirmed at Visit 2,
• Extending through the epidermis and dermis and may have reached bone, tendon or joint capsule (Grade 1 to grade 2 according to Wagner Classification System for diabetic foot ulcer),
• Present for ≥4 weeks prior to Visit 1 despite appropriate care, and
• Ulcer without clinical signs and symptoms of infection.
• Adequate arterial blood supply to the lower leg or foot under study, to be measured either by doppler ultrasonography, ankle brachial pressure index (ABPI) ≥0.50, or toe pressure \>30 mmHg.
• Note: For subjects with 0.7\>ABPI ≧0.5, adequate treatments must be provided to the subject for improving circulation by medication or surgical procedures, etc. ABPI is the ratio of the highest systolic blood pressure of the dorsalis pedis or posterior tibial arteries of each leg to the highest of the left and right arm brachial systolic blood pressure.
• Female subjects of childbearing potential must have a negative serum pregnancy test prior to first dose of study medication and must agree to use an effective method of contraception throughout the study. Females who are surgically sterile or have been postmenopausal for at least 1 year (12 consecutive months without menses) are exempted from these criteria. Effective methods of contraception include oral contraceptives, injectable or implantable hormonal methods, intrauterine devices, tubal ligation (if performed more than 1 year prior to screening), or double barrier contraception (e.g., diaphragm+condom).
• Subject agrees to comply with ulcer care regimen for the duration of the study.
• Subject is able to understand and sign an informed consent form and willing to comply with all study procedures.

You may not qualify if:

• Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation (the presence of infection is defined by ≥2 classic findings of inflammation or purulence).
• Presence of cellulitis or gangrene on the lower leg or foot under study.
• Presence of another open ulcer \<2 cm away from target ulcer, on the same lower leg or foot.
• Target ulcer on the heel.
• Target ulcer caused primarily by untreated arterial insufficiency or with an etiology not related to diabetes.
• Subjects with ulcers related to an incompletely healed amputation wound.
• Acute or chronic osteomyelitis affecting the area of the target ulcer.
• Any structural deformity of the lower leg or foot under study that would prevent off-loading of the target ulcer, including acute Charcot osteoarthropathy.
• Previous use of a platelet-derived product (e.g., becaplermin) or other growth factors on the target ulcer within 4 weeks prior to Visit 1.
• Previous use of autologous graft or allogeneic graft, or dermal substitute or living skin equivalent (e.g., Dermagraft® or Apligraf®) on the target ulcer or hyperbaric oxygen therapy within 2 weeks prior to Visit 1.
• Use of any topical antimicrobials or enzymatic debridement treatment, to treat the target ulcer within 7 days prior to Visit 1.
• Treatment with systemic corticosteroids other than for inhalation, immunosuppressive agents, radiation therapy, or chemotherapeutic agent within 30 days prior to Visit 1 or likelihood to receive any of these therapies during study participation.
• History of cancer or current cancer, with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to administration of any study agent).
• Vasculitis, connective tissue diseases, or any medical conditions known to impair ulcer healing, other than diabetes.
• Sickle cell disease.

Sponsors & Collaborators

• Blue Blood Biotech Corp.: lead

Study Sites (6)

E-DA Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Shuangho Hospital

New Taipei City, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Shih-Chen Pan, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 25, 2019
• Study Start: March 28, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2023
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

TW (6)