| Eligibility |
Inclusion Criteria for Healthy Volunteers:
1. Healthy male or female volunteers, 18 to 55 years old
2. Females must be of non-childbearing potential
3. Males must agree to follow the protocol-specified contraception guidance
4. Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg
5. Non-smoker, defined as an individual who has not smoked previously and/or who has
discontinued smoking or the use of nicotine/nicotine-containing products at least 3
months before Screening
6. Able to provide signed informed consent
Exclusion Criteria for Healthy Volunteers:
1. Regular consumption of alcohol within 6 months prior to Screening, or use of soft
drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as
cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or
urine test results for drugs of abuse or alcohol at Screening or Admission
2. Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7
days prior to the first dose of study drug, or platelets in the 6 weeks prior to the
first dose of study drug
3. History or evidence of a clinically significant disorder, condition, or disease that
could pose a risk to subject safety or interfere with the study, or would make the
subject unsuitable for participation, eg, respiratory, renal, hepatic,
gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or
psychiatric disease
4. Female who is breastfeeding or who has a positive serum pregnancy test at Screening or
a positive urine pregnancy test on Day -1
Inclusion Criteria for Adults with IgAN:
1. Male or female =18 years old at Screening
2. Women of child-bearing potential (WOCBP; per CTFG 2014) must agree to follow the
protocol-specified contraception guidance throughout the study (from Screening through
approximately 6 months after the final dose of study drug)
3. Males must agree to follow the protocol-specified contraception guidance throughout
the study (from Screening through approximately 6 months after the final dose of study
drug)
4. BMI between 18 and 40 kg/m^2, inclusive, at Screening with a weight of at least 50 kg
5. Diagnosis of IgAN verified by biopsy taken within the past 10 years
6. Urine protein = 0.5 g/24h; OR UPCR = 0.5 g/g (or = 50 mg/mmol)
7. eGFR (per Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or
measured GFR = 30 mL/min per 1.73 m^2
8. Stable on an optimized dose of angiotensin converting enzyme (ACE) inhibitors and/or
angiotensin-receptor blockers (ARBs) for at least 3 months prior to Screening or
intolerant to ACE/ARB
Exclusion Criteria for Adults with IgAN:
1. Known or suspected allergy or hypersensitivity to any component of BION-1301, or
history of severe hypersensitivity reaction to any monoclonal antibody
2. Donated blood in the 3 months prior to the first dose of study drug; plasma in the 7
days prior to the first dose of study drug; or platelets in the 6 weeks prior to the
first dose of study drug
3. Participated in any other study in which receipt of an investigational new drug, or
investigational device occurred within 28 days, or 5 half-lives (whichever is longer)
of first dose of study drug in the present study
4. Secondary forms of IgAN as defined by the treating physician (eg, Henoch-Schönlein
purpura patients and those with associated alcoholic cirrhosis)
5. Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or
any other form of immunosuppressive therapy within 3 months prior to the first dose of
study drug
PART 4 Eligibility Criteria for Re-treatment Due to Evidence of Disease Progression (Option
1) Inclusion Criteria for Re-treatment Due to Evidence of Disease Progression
1. Completed Part 3 of the study through Week 124 and entered the 52-week follow-up
period.
2. UPCR = 0.5 g/g AND = 30% increase from EOT (Week 124). Both proteinuria criteria must
be met by a 24-hour urine assessment during the 52-week follow-up period. In addition
to the scheduled assessments, investigators may order periodic FMV assessments (for
example monthly) to follow a patient more closely. Based on an off-schedule FMV
result, or other laboratory or clinical evidence, investigators may order an
off-schedule 24-urine collection to confirm disease progression.
Exclusion Criteria for Re-treatment Due to Evidence of Disease Progression
1. Based on the Investigator's judgment, the patient would not benefit from resuming
treatment with BION-1301 or there is a safety concern for the individual patient which
outweighs the expected benefit from resuming treatment.
Eligibility Criteria for Optional Re-treatment (Option 2) Inclusion Criteria for Optional
Re-treatment 1. Completed Part 3 of the study through Week 124 and completed of the 52-week
follow-up period.
Exclusion Criteria for Optional Re-treatment
1. Based on the Investigator's judgment, the patient would not benefit from resuming
treatment with BION-1301 or there is a safety concern for the individual patient which
outweighs the expected benefit from resuming treatment.
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